Accuracy of CADx System for White Light Colonic Polyp Characterization

Colonic Polyp Clinical Trial

— GIC  

Official title:

Accuracy and Feasibility of CADx System for White Light Colonic Polyp Characterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492656
• Other study ID #: 41/2022
• Status: Completed
• Start date: August 5, 2022
• Est. completion date: November 5, 2022

Study information

• Verified date: March 2024
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The endoscopist performances in the optical diagnosis (OD) of colonic polyps with the available technologies vary widely across centers and across endoscopists. The OD process is strictly related to the operator training and expertise. Most of the available studies in optical characterization have been carried out by expert endoscopist in tertiary high volume centers, and weren't replied on large unselected populations. For these reasons, at the moment the optical characterization of polypoid lesions can't replace, in the everyday clinical practice, the histopathological evaluation of resected polyps. Artificial intelligence (AI)-based systems have the potential to make optical characterization process of colonic polyps easier and more reliable, thus supporting the endoscopist in the application of leave-in-situ and of resect-and-discard strategies. The implementation of such strategies would lead to a significant economic saving and a decrease of risks and complications related to unnecessary polypectomy. GI-Genius System (Medtronic Inc, Minneaopolis, USA) is a CNN-based algorithm allowing an automatic OD of colonic polyps. This system does not require dedicated light setting for polyp evaluation as it works with white light high definition images, which are the actual standard in every endoscopic unit. During colonoscopy, when a polyp is framed within the screen, a green detection box surrounds the polyp and the system automatically provides (whenever possible) the optical diagnosis labeling the polyp as "adenoma or non-adenoma". When the automatic polyp charaterization is unfeasible the label "no prediction" appears. Nowadays only few data about the feasibility and performances of this system in clinical practice are available. In addition published studies are mostly focused on technical rather thann clinical issues. The present prospective observational trial is primarily aimed at evaluating the diagnostic accuracy of optical characterization of colonic polyps <= 1 cm using GI-Genius System in daily clinical practice, having histopathology examination as reference standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 5, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Consecutive outpatients undergoing colonoscopy for one of the following indication:

• FIT-based screening program

• voluntary screening

• post-polipectomy surveillance

• gastrointestinal symptoms

• family history of colorectal cancer.

Exclusion Criteria:

• urgent colonoscopy

• patients in which polyps could not be resected (e.g ongoing anticoagulation therapy)

• patients with past colorectal cancer or polyposis syndrome

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Polyp
• Colonic Polyps
• Polyps

Locations

Country	Name	City	State
Italy	Gastroenterology Unit, Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of CADx in evaluating small colonic polyps	Numer of correctly characterized polyps using AI/total number of detected polyps	Entire study duration (3 months)
Secondary	Feasibility of CADx in evaluating small colonic polyps	Number of characterizable polyps using AI/total number of detected polyps	Entire study duration (3 months)
Secondary	Sensitivity	CADx sensitivity (rate of TP/TP+FN) will be calculated having histopathology as reference standard and according to polyp size and location	Entire study duration (3 months)
Secondary	specificity	CADx specificity (rate of TN/TN+FP) will be calculated having histopathology as reference standard according to polyp size and location	Entire study duration (3 months)
Secondary	Positive predictive value	CADx positive predictive value (rate of TP/TP+FP) will be calculated having histopathology as reference standard according to polyp size and location	Entire study duration (3 months)
Secondary	Negative predictive value	CADX negative predictive value (rate of TN/TN+FN) will be calculated having histopathology as reference standard according to polyp size and location	Entire study duration (3 months)